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Cimicifuga racemosa transfer from OTC drug to dietary supplement status requested.

This article was originally published in The Tan Sheet

Executive Summary

CIMICIFUGA RACEMOSA TRANSFER FROM OTC DRUG TO DIETARY SUPPLEMENT STATUS is requested by Direct Pharmaceuticals Limited in a July 24 citizen petition to FDA. Valletta, Malta-based Direct Pharmaceuticals is asking the agency to delete the ingredient cimicifuga racemosa from the OTC menstrual drug products monograph and instead consider it a dietary supplement in the "appropriate dietary supplement rulemaking" under the Dietary Supplement Health & Education Act. The Direct Pharmaceuticals submission was filed in conjunction with Schaper & Brummer GmbH, the manufacturer of the product.
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